Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke — AMETIS  

Stroke Clinical Trial

Official title: Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Patients With Ischemic Stroke: a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, efficacy, and safety of autologous transplantation of ex vivo expanded bone marrow stromal cells (BMSCs)and endothelial progenitor cells (EPCs) for treatment of patients with ischemic stroke.

Clinical Trial Description

This study is a multi-center, single-blind, randomized, parallel controlled trail. Patients with acute cerebral infarcts within the middle cerebral arterial territory and with severe neurological deficits will be enrolled and randomly allocated into 3 groups: autologous BMSCs transplantation group, autologous EPCs transplantation group and Placebo control group. Randomization codes were established by the study statistician and were revealed only to the stem cell laboratory technician responsible for separating the cells into aliquots or preparing the placebo material. All patients will undergo a Bone Marrow aspiration procedure at 7 days after symptom onset. BMSCs and EPCs will be expanded ex vivo and then intravenously infused into own body, respectively. The control group will not receive cell therapy. Observe will followed for up to 1 year after the onset. Neurological score, neuroimaging, mortality of any cause, side effects, and new-onset comorbidities will be monitored and compared between each groups. ;

Related Conditions & MeSH terms

• Infarction
• Infarction, Middle Cerebral Artery
• Stroke

• NCT number: NCT01468064
• Study type: Interventional
• Source: Southern Medical University, China
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2011
• Completion date: March 2017